Industry Experts: The Patent Dance Still Has Value, But Uncertainty Lies Ahead

The Center for Biosimilars Staff

The US Supreme Court’s recent ruling in the case of Sandoz v Amgen led to industry speculation that biosimilar applicants could lack incentive to participate in the information exchange process with reference product sponsors, or the so-called “patent dance,” provided for under the Biologics Price Competition and Innovation Act (BPCIA).

The US Supreme Court’s recent ruling in the case of Sandoz v Amgen led to industry speculation that biosimilar applicants could lack incentive to participate in the information exchange process with reference product sponsors, or the so-called “patent dance,” provided for under the Biologics Price Competition and Innovation Act (BPCIA).

Yet as Patterson Belknap Webb & Tyler attorneys Irena Royzman and Nathan Monroe-Yavneh write at the firm’s Biologics Blog, following the steps of the patent dance still holds significant benefits for biosimilar developers. According to Royzman and Monroe-Yavneh, one of the most compelling benefits of the patent dance is that it allows a biosimilar applicant to limit the scope of patents that can be addressed by the first wave of BPCIA litigation.

Under the BPCIA, the reference product sponsor and the biosimilar applicant engage in patent litigation in 2 stages: the first stage begins with a negotiation over which patents to litigate. While the reference manufacturer may hope to bring all of the patents it wants to assert in the first wave of litigation, the biosimilar applicant can cap the number of patents that it wants to challenge during the initial period. The parties then exchange lists of patents, with each list capped at the number determined by the biosimilar developer, and concur on the final range of patents that are then litigated.

AbbVie and Boehringer Ingelheim’s (BI) recent litigation over adalimumab (Humira) illustrates the benefits of the information exchange for the biosimilar developer: while AbbVie claimed that BI will infringe on 74 of its patents, and proposed a single phase of litigation for all of them, BI was able to limit the patent list for the first wave to 8.

Royzman and Monroe-Yavneh also point out that following the steps of the BPCIA gives applicants control over the timing of litigation. The second wave of patent litigation, during which all remaining patents that the reference product sponsor wishes to assert can be litigated, commences after a biosimilar developer files its 180-day notice of commercial marketing. That trigger leaves the timing of the second, and potentially more extensive, litigation period in the hands of the biosimilar applicant.

However, as Ha Kung Wong of Fitzpatrick, Cella, Harper and Scinto told The Center for Biosimilars® in a recent interview, those benefits may not be compelling for biosimilar applicants currently seeking to launch products. “We’ve already seen that some biosimilar applicants would prefer to forego the patent dance entirely,” said Wong. “Currently, the biosimilars in late-stage development are for blockbuster drugs that have been on the market since the 1990s. And because they’ve been on the market for so long, many are covered by only a handful of unexpired patents. So under those circumstances, biosimilar applicants may not see any incentive to participate in this dance.”

That trend could change, however, as biosimilar developers shift their focus to newer biologics. According to Wong, “biosimilar applicants will begin targeting newer drugs not long after data exclusivity expires. Under those circumstances, with larger patent portfolios and longer expiration dates, the certainty that the patent dance provides could be valuable to biosimilar applicants.”

However, the Federal Circuit has not yet clarified a lingering question of the Sandoz v Amgen ruling—namely, whether injunctions are available under state law for the failure to provide initial disclosures. The outcome of that question could have bearing on applicants’ willingness to participate in the patent dance. According to Wong, “If the initial disclosures under the BPCIA are essentially optional, biosimilar applicants may decide there isn’t enough of an incentive to participate, and may choose to force brand drug makers to operate in the dark as they assert basically all patents at once after they receive notice of commercial marketing.”

For both biosimilar developers and reference product sponsors, Wong says, “There’s still plenty to be concerned about.”